Sr Metrology Engineer

Optima Organizational Solutions

Mexicali

Sur place

MXN 900 000 - 1 400 000

Plein temps

Il y a 11 jours

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Résumé du poste

Optima Organizational Solutions seeks a Senior Metrology Engineer to lead the metrology lab at a Mexicali medical devices site, overseeing measurement system development, validation, and continuous improvement to ensure quality and regulatory compliance.

The role requires 7+ years in metrology, 5+ years in medical device manufacturing, advanced English, and strong leadership. You will program CMMs (Zeiss/Hexagon), perform MSA/GM&R, and support ISO 13485 and FDA-regulated environments.

Qualifications

  • Bachelor's degree in Mechanical, Manufacturing, Industrial, Mechatronics Engineering or related discipline.
  • 7+ years of metrology experience, including 5+ years in medical device manufacturing.
  • Experience with CMM programming, dimensional inspection, GD&T, MSA, and TMV.

Responsabilités

  • Develop and validate measurement methods (MSA, Gage R&R, TMV).
  • Program and qualify Zeiss and Hexagon CMMs using Calypso and PC-DMIS.
  • Interpret GD&T to establish inspection methods and acceptance criteria.
  • Support laboratory calibration, equipment qualification, maintenance, and traceability.
  • Assist with APQP/PPAP, process validation, and new product introductions.
  • Analyze data, troubleshoot issues, and improve inspection processes.
  • Support ISO 13485 and ISO 17025 compliance and audits.
  • Mentor and develop metrology team.

Connaissances

Metrology expertise
Advanced English
Leadership
Problem-solving
Communication

Formation

Bachelor's degree in Mechanical/Manufacturing/Industrial/Mechatronics Engineering

Outils

CMM programming
PC-DMIS
Calypso
Zeiss/Hexagon CMMs
Minitab/JMP

Description du poste

Our client, a global manufacturing solutions partner specializing in precision injection molding, custom rigid plastic packaging, and contract manufacturing; has requested us to search for a Sr Metrology Engineer to support their Mexicali, B.C. medical devices manufacturing site, to lead measurement systems development, validation, and improvement. This role provides technical leadership for the metrology laboratory, ensuring accurate, reliable measurements that support product quality, manufacturing, and regulatory compliance.

Key Responsibilities
  • Develop and validate measurement methods, including Measurement System Analysis (MSA), Gage R&R, and Test Method Validation (TMV).
  • Program and qualify Zeiss and Hexagon CMMs using Calypso and PC-DMIS.
  • Interpret engineering drawings and GD&T requirements to establish inspection methods and acceptance criteria.
  • Support laboratory calibration, equipment qualification, maintenance, and measurement traceability.
  • Support new product introductions, process validation and APQP/PPAP activities.
  • Analyze measurement data, troubleshoot issues, and improve inspection processes.
  • Support ISO 13485 and ISO 17025 compliance, documentation, and customer and regulatory audits.
  • Help build and develop the metrology team through technical guidance and coaching.
Qualifications
  • Bachelor's degree in Mechanical, Manufacturing, Industrial, Mechatronics Engineering, or a related discipline.
  • 7+ years of metrology experience, including 5+ years supporting medical device manufacturing.
  • Experience with CMM programming, dimensional inspection, GD&T, MSA, and TMV.
  • Working knowledge of statistical analysis tools such as Minitab or JMP, SPC, and process capability.
  • Experience supporting ISO 13485 and FDA-regulated manufacturing environments; familiarity with ISO 17025.
  • Advanced English, written and verbal.
  • Strong problem-solving, communication, and technical leadership skills.
Preferred:
  • Relevant ASQ, Six Sigma, GD&T, or ISO certifications.
  • Experience with 3D imaging or advanced geometric analysis is a plus.
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